Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

Shots: The US FDA has granted 510(k) clearance to Zipline Access Catheters to treat acute ischemic strokes Zipline improves delivery of a large (070) & superbore (088) aspiration catheter to enhance trackability & simplify neuro-interventional procedures for faster as well as more efficient stroke treatment. Zipline also optimizes clot removal & improves success rates…

ByRidhi RastogiMarch 17, 2025

NEWS

AstraZeneca and Alteogen Enter an Exclusive License Deal for ALT-B4 to Develop & Market Subcutaneous Formulations of Multiple Oncology Drugs

Shots: Alteogen has granted AstraZeneca global rights of ALT-B4 to develop & commercialize SC formulations of multiple oncology assets, while Alteogen will be responsible for clinical & commercial supply of ALT-B4 As per the deal, Alteogen will receive an upfront, along with development, regulatory, & sales milestones, plus royalties on sale of commercialized products…

ByRidhi RastogiMarch 17, 2025

NEWS

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

Shots: Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25 Pts received an initial loading dose…

ByRidhi RastogiMarch 17, 2025

NEWS

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

Shots: AbbVie has reported final analysis data from P-III (MIRASOL) trial assessing Elahere vs CT in FRα+ PROC pts (n= 453) who had previously received 1-3L of therapy At 30.5mos. mFU, trial showed 37% improved PFS (mPFS: 5.59 vs 3.98mos.) & superior ORR (41.9% vs 15.9%), while mOS was 16.85 vs 13.34mos., with 32% reduced…

ByRidhi RastogiMarch 17, 2025

NEWS

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots: Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024 Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…

ByRidhi RastogiMarch 17, 2025

NEWS

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Shots: The US FDA has granted 510(k) clearance to MONARCH QUEST, an AI-powered navigation tech for improved robotic-assisted bronchoscopy MONARCH QUEST features a scope-in-sheath design & continuous vision, utilizing NVIDIA RTX platform to boost its computational power by 260% for enhanced accuracy. It also allows integration with GE HealthCare’s OEC 3D CBCT Imaging System to…

ByRidhi RastogiMarch 17, 2025

NEWS

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

Shots: Kemin Industries has launched Prosidium to improve biosecurity in animal feed and global food supply Prosidium is based on peroxy acids, which disrupts pathogen cell membranes to reduce Salmonella risk & viral transmission in animal feed, while the residual acids offer continuous feed protection Additionally, Prosidium’s ingredients are approved by various regulatory bodies incl.…

ByRidhi RastogiMarch 17, 2025

NEWS

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Shots: The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL In pts treated in 3L+ setting, study met…

ByRidhi RastogiMarch 17, 2025

NEWS

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots: The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

ByRidhi RastogiMarch 13, 2025

NEWS

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

Shots: Kemin Industries has launched Prosidium to improve biosecurity in animal feed and global food supply Prosidium is based on peroxy acids, which disrupts pathogen cell membranes to reduce Salmonella risk & viral transmission in animal feed, while the residual acids offer continuous feed protection Additionally, Prosidium’s ingredients are approved by various regulatory…

ByRidhi RastogiMarch 13, 2025

Ridhi Rastogi

Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters

AstraZeneca and Alteogen Enter an Exclusive License Deal for ALT-B4 to Develop & Market Subcutaneous Formulations of Multiple Oncology Drugs

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

J&J MedTech Reports the US FDA‘s 510(k) Clearance of MONARCH QUEST for Robot-Assisted Bronchoscopy

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Kemin Industries Launches Prosidium to Improve Biosecurity in Animal Feed Industry & Supply

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